Attention Deficit Hyperactivity Disorder MedDRA version: 18.0 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 100000004873
Conditions
Sponsors
Janssen Korea Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for Attention Deficit Hyperactivity Disorder (ADHD) and are considered to require medication therapy - Participants that agreed to observe visit schedules and willingly complete the evaluation defined by participant (possibly to be completed by parents/guardians) during the treatment period - Participants and parents/guardians that are able to understand the participation procedures of the research and spontaneously request the discontinuation therein at any time - Participants that offered spontaneous consent for participation - Participants whose guardian/legal representative provided spontaneous written consent Are the trial subjects under 18? yes Number of subjects for this age range: 115 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Hypersensitivity to methylphenidate HCl - Participants diagnosed with major depression or anxiety disorders according to DSM-IV Diagnostic criteria and who requires drug therapy - Participants with a history of bipolar disorder, psychotic disorder, and substance abuse disorder ordiagnosed with an overall developmental disorder, organic brain disorder, seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) disorder, movement disorder requiring the medication therapy, or with a family history of Tourette's syndrome (a neuropsychological disorder that causes marked distress or significant impairment in social, occupational, or other important areas of functioning) - Taken Osmotic Release Oral System (OROS) Methylphenidate within 3 months prior to screening - Currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant (drug used to stop seizures) or health food supplements that may have a central nervous system activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill changes in Korean participants with Attention-Deficit Hyperactivity Disorder (ADHD).;Secondary Objective: Not applicable;Primary end point(s): - Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score - Clinical Global Impression - Severity (CGI-S) Score - Clinical Global Impression - Improvement (CGI-I) Score - Learning Skill Test (LST) Total Score;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Omission Errors and Commission Errors - Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability - Digit Span Test Score - Finger Window (FW) Test Score - Controlled Oral Words Association Test (COWAT) Score - Stroop Test Score for Reaction Time - Stroop Test Score for False Reaction - Stroop Test Score for Ratio Interference;Timepoint(s) of evaluation of this end point: Baseline and Week 12 | — |
Countries
Korea, Republic of
Contacts
Public ContactClinical Registry Group-JB BV
Janssen Research and Development
Outcome results
None listed